Novel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Depression, Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/11/2018 |
| Start Date: | April 3, 2018 |
| End Date: | March 2019 |
| Contact: | Charles T Taylor, PhD |
| Email: | c1taylor@ucsd.edu |
| Phone: | 858.534.9446 |
Novel Behavioral Intervention to Target Social Reward Sensitivity and Attachment
The overall goal of this project is to develop a novel transdiagnostic behavioral treatment
-- social approach training -- intended to enhance positive social connections in individuals
with elevated anxiety and/or depression. Social relationship impairments are pervasive and
debilitating consequences of anxiety and depression. Existing treatments have some beneficial
impact on social functioning; however, many people continue to have few and/or poor quality
relationships following treatment, even after experiencing symptom relief. This study will
evaluate the effects of social approach training on the brain systems that have been shown to
be important for establishing positive connections with others. Approximately 60 individuals
(ages 18-55) seeking treatment for anxiety or depression will participate in this study.
Participants will be randomly assigned with equal probability to one of two versions of
social approach training (5 or 10 sessions) or a waitlist (assessment only) control group.
Participants will be assessed at baseline and post-treatment and compared on measures
assessing brain responses to social reward (primary outcome), as well as physiological,
behavioral, and emotional responses to social reward (secondary outcomes). It is hypothesized
that participants assigned to social approach training will display greater increases from
pre- to post-treatment in activity in brain systems that regulate the processing of social
reward (e.g., striatum) relative to participants in the control group. This study will also
determine whether the 5- vs. 10-session versions of the treatment program result in
meaningful differences, compared to each other, in how the brain responds to social reward.
-- social approach training -- intended to enhance positive social connections in individuals
with elevated anxiety and/or depression. Social relationship impairments are pervasive and
debilitating consequences of anxiety and depression. Existing treatments have some beneficial
impact on social functioning; however, many people continue to have few and/or poor quality
relationships following treatment, even after experiencing symptom relief. This study will
evaluate the effects of social approach training on the brain systems that have been shown to
be important for establishing positive connections with others. Approximately 60 individuals
(ages 18-55) seeking treatment for anxiety or depression will participate in this study.
Participants will be randomly assigned with equal probability to one of two versions of
social approach training (5 or 10 sessions) or a waitlist (assessment only) control group.
Participants will be assessed at baseline and post-treatment and compared on measures
assessing brain responses to social reward (primary outcome), as well as physiological,
behavioral, and emotional responses to social reward (secondary outcomes). It is hypothesized
that participants assigned to social approach training will display greater increases from
pre- to post-treatment in activity in brain systems that regulate the processing of social
reward (e.g., striatum) relative to participants in the control group. This study will also
determine whether the 5- vs. 10-session versions of the treatment program result in
meaningful differences, compared to each other, in how the brain responds to social reward.
Inclusion Criteria:
1. Score on the PHQ-9 is 10 or higher and/or score on the OASIS is 8 or higher.
2. Social Connectedness Scale Revised (SCSR) < 90
3. Sheehan Disability Scale (SDS) - Social Domain ≥ 5
4. Between the ages of 18-55, inclusive.
5. Have sufficient proficiency in English language to understand and complete interviews,
questionnaires, and all other study procedures.
Exclusion Criteria:
1. No telephone or easy access to telephone.
2. Any substance use disorder in the past year except subjects with mild alcohol,
nicotine, caffeine, and marijuana use disorders will be permitted in the study.
3. Bipolar I or Psychotic disorders.
4. Moderate to severe traumatic brain injury with evidence of neurological deficits,
neurological disorders, or severe or unstable medical conditions that might be
compromised by participation in the study.
5. Current and regular use (more days than not during the past 30 days) of a medication
that could affect brain functioning, such as anxiolytics, antipsychotics,
antidepressants, mood stabilizers, beta-blockers, sleep medications, opioids/codeine,
migraine medications.
6. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body
(shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips,
hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal
plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever
been a metal worker/welder, history of eye surgery/eyes washed out because of metal,
vision problems uncorrectable with lenses, inability to lie still on one's back for 60
minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body
piercings, and pregnancy.
7. non-correctable vision or hearing problems, as some tests require intact sensory
functioning.
8. Concurrent psychosocial treatment: Participants completing ongoing empirically
supported psychosocial treatment for the presenting problem will be required to meet
12-week stability criteria so that symptom changes as a result of other psychosocial
treatments are not confounded with changes due to the research.
9. Inability to complete the initial assessment battery or treatment sessions.
10. Clinical conditions assessed by the interviewer that necessitate more imminent
clinical care (e.g., active suicidal ideation): These criteria are in place so
participants with these other, more several symptoms can be referred for appropriate
mental health services.
We found this trial at
1
site
9452 Medical Center Drive
La Jolla, California 92037
La Jolla, California 92037
Phone: 858-534-6407
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